MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ESTRADIOL III ASSAY; RADIOIMMUNOASSY, ESTRADIOL

Catalog Number	06656021190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of discrepant results for 1 patient sample tested for elecsys estradiol iii assay (estradiol iii) and elecsys fsh (fsh) on a cobas 6000 e601 module.The estradiol iii result from the e601 module was 769.20 pmol/l.The sample was repeated twice on the e601 module with results of 800.8 pmol/l and 804.6 pmol/l.The fsh result from the e601 module was 1.31 iu/l.The doctor questioned the estradiol result as it was not consistent with the patient¿s condition.The sample was repeated by a competitor method, and the estradiol result was < 55.1 pmol/l, and the fsh result was 1.85 miu/ml.This medwatch will cover estradiol iii.Refer to medwatch with a1 patient identifier pt- (b)(6) for information on the fsh results.
Additional Manufacturer Narrative
The competitor method was beckman.The e601 module serial number was (b)(6).The sample was requested for investigation.
Additional Manufacturer Narrative
Calibration and qc were acceptable.The sample was received for investigation.The investigation reproduced the customer's high estradiol result: 222 pg/ml (815.05 pmol/l).Upon further investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: ELECSYS ESTRADIOL III ASSAY
• Common Device Name: RADIOIMMUNOASSY, ESTRADIOL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22506723
• Report Number: 1823260-2025-02146
• Device Sequence Number: 9264868
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 06656021190
• Device Lot Number: 84459401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian